Efficacy Comparison Between Two Kind of Chinese Herbal Formulas on Traditional Chinese Medicine Syndromes Among Chronic Hepatitis Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Traditional Chinese Medicine symptom scale
研究概览
简要总结
Although the incidence of Hepatitis B has been decreased a lot recently years, there are still quite a few chronic hepatitis B patients in China. The anti-virus drugs of western medicine such as Entecavir and Tenofovir have been proved effective on decreasing the serum hepatitis B virus (HBV) level, on the other hand, Chinese materia medica showed effective on TCM syndromes of chronic hepatitis B (CHB) such as hypochondriac pain, jaundice and abdominal mass. Besides, the hepatic fibrosis could be delayed after the appropriate treatment of TCM. This study is a multicenter, randomized, open label, parallel group clinical trial to evaluate the efficacy of two different traditional Chinese medicine (TCM) herbal treatment on chronic hepatitis B.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18<=age at treatment<=65 years old
- •Was diagnosed as chronic hepatitis B (ICD10:K73.901) and one of the following Chinese syndromes: hypochondriac pain (TCD:BNG010), jaundice(TCD:BNG020) or abdominal mass (TCD:BNG040).
排除标准
- •Combined with other virus hepatitis or alcoholic hepatitis
- •Combined with autoimmune disease
- •Combined with liver cancer or cirrhosis
- •Combined with severe hepatitis with or without complications
- •Combined with unstable cardio-cerebrovascular disease
- •Combined with severe lung, kidney, endocrine system, nervous system and hematological system diseases
- •Combined with Tuberculosis
- •Chronic hepatitis patients with ongoing INF treatment
- •Woman with pregnancy or breasting feeding
- •Mental disorder and can not express self clearly
- •Cannot speak Chinese
- •Allergic constitution or allergy to multiple drugs
- •Refuse to enroll into the study
研究组 & 干预措施
Standard CMF
Standard Chinese medical formulas (CMF) for the corresponding TCM syndromes, plus an anti-virus treatment of western drugs (such as Entecavir or Tenofovir).
- Yinchengao Decoction plus Ganlu Detoxification Pill for the Traditional Chinese Medicine (TCM) syndrome: Damp-heat blocking middle jiao
- Chaihu Shugan San for the TCM syndrome: Liver depression and qi stagnation
- Xiaoyao powder for the TCM syndrome: Stagnation of liver qi and spleen deficiency.
- Yiguan Decoction for the TCM syndrome: Yin deficiency of liver and kidney
- Fuzilizhong Decoction plus Jinkui Shenqi Bolus for the TCM syndrome: Yang deficiency of spleen and kidney
- Ge Xia Zhu Yu Decoction for the TCM syndrome: Internal blood stasis
干预措施: Standard - Yinchengao Decoction plus Ganlu Detoxification Pill (Drug)
Standard CMF
Standard Chinese medical formulas (CMF) for the corresponding TCM syndromes, plus an anti-virus treatment of western drugs (such as Entecavir or Tenofovir).
- Yinchengao Decoction plus Ganlu Detoxification Pill for the Traditional Chinese Medicine (TCM) syndrome: Damp-heat blocking middle jiao
- Chaihu Shugan San for the TCM syndrome: Liver depression and qi stagnation
- Xiaoyao powder for the TCM syndrome: Stagnation of liver qi and spleen deficiency.
- Yiguan Decoction for the TCM syndrome: Yin deficiency of liver and kidney
- Fuzilizhong Decoction plus Jinkui Shenqi Bolus for the TCM syndrome: Yang deficiency of spleen and kidney
- Ge Xia Zhu Yu Decoction for the TCM syndrome: Internal blood stasis
干预措施: Entecavir or Tenofovir (Drug)
Standard CMF
Standard Chinese medical formulas (CMF) for the corresponding TCM syndromes, plus an anti-virus treatment of western drugs (such as Entecavir or Tenofovir).
- Yinchengao Decoction plus Ganlu Detoxification Pill for the Traditional Chinese Medicine (TCM) syndrome: Damp-heat blocking middle jiao
- Chaihu Shugan San for the TCM syndrome: Liver depression and qi stagnation
- Xiaoyao powder for the TCM syndrome: Stagnation of liver qi and spleen deficiency.
- Yiguan Decoction for the TCM syndrome: Yin deficiency of liver and kidney
- Fuzilizhong Decoction plus Jinkui Shenqi Bolus for the TCM syndrome: Yang deficiency of spleen and kidney
- Ge Xia Zhu Yu Decoction for the TCM syndrome: Internal blood stasis
干预措施: Standard - Ge Xia Zhu Yu Decoction (Drug)
Standard CMF
Standard Chinese medical formulas (CMF) for the corresponding TCM syndromes, plus an anti-virus treatment of western drugs (such as Entecavir or Tenofovir).
- Yinchengao Decoction plus Ganlu Detoxification Pill for the Traditional Chinese Medicine (TCM) syndrome: Damp-heat blocking middle jiao
- Chaihu Shugan San for the TCM syndrome: Liver depression and qi stagnation
- Xiaoyao powder for the TCM syndrome: Stagnation of liver qi and spleen deficiency.
- Yiguan Decoction for the TCM syndrome: Yin deficiency of liver and kidney
- Fuzilizhong Decoction plus Jinkui Shenqi Bolus for the TCM syndrome: Yang deficiency of spleen and kidney
- Ge Xia Zhu Yu Decoction for the TCM syndrome: Internal blood stasis
干预措施: Standard - Chaihu Shugan San (Drug)
Standard CMF
Standard Chinese medical formulas (CMF) for the corresponding TCM syndromes, plus an anti-virus treatment of western drugs (such as Entecavir or Tenofovir).
- Yinchengao Decoction plus Ganlu Detoxification Pill for the Traditional Chinese Medicine (TCM) syndrome: Damp-heat blocking middle jiao
- Chaihu Shugan San for the TCM syndrome: Liver depression and qi stagnation
- Xiaoyao powder for the TCM syndrome: Stagnation of liver qi and spleen deficiency.
- Yiguan Decoction for the TCM syndrome: Yin deficiency of liver and kidney
- Fuzilizhong Decoction plus Jinkui Shenqi Bolus for the TCM syndrome: Yang deficiency of spleen and kidney
- Ge Xia Zhu Yu Decoction for the TCM syndrome: Internal blood stasis
干预措施: Standard - Xiaoyao powder (Drug)
Standard CMF
Standard Chinese medical formulas (CMF) for the corresponding TCM syndromes, plus an anti-virus treatment of western drugs (such as Entecavir or Tenofovir).
- Yinchengao Decoction plus Ganlu Detoxification Pill for the Traditional Chinese Medicine (TCM) syndrome: Damp-heat blocking middle jiao
- Chaihu Shugan San for the TCM syndrome: Liver depression and qi stagnation
- Xiaoyao powder for the TCM syndrome: Stagnation of liver qi and spleen deficiency.
- Yiguan Decoction for the TCM syndrome: Yin deficiency of liver and kidney
- Fuzilizhong Decoction plus Jinkui Shenqi Bolus for the TCM syndrome: Yang deficiency of spleen and kidney
- Ge Xia Zhu Yu Decoction for the TCM syndrome: Internal blood stasis
干预措施: Standard - Yiguan Decoction (Drug)
Standard CMF
Standard Chinese medical formulas (CMF) for the corresponding TCM syndromes, plus an anti-virus treatment of western drugs (such as Entecavir or Tenofovir).
- Yinchengao Decoction plus Ganlu Detoxification Pill for the Traditional Chinese Medicine (TCM) syndrome: Damp-heat blocking middle jiao
- Chaihu Shugan San for the TCM syndrome: Liver depression and qi stagnation
- Xiaoyao powder for the TCM syndrome: Stagnation of liver qi and spleen deficiency.
- Yiguan Decoction for the TCM syndrome: Yin deficiency of liver and kidney
- Fuzilizhong Decoction plus Jinkui Shenqi Bolus for the TCM syndrome: Yang deficiency of spleen and kidney
- Ge Xia Zhu Yu Decoction for the TCM syndrome: Internal blood stasis
干预措施: Standard - Fuzilizhong Decoction plus Jinkui Shenqi Bolus (Drug)
Advanced CMF
Advanced TCM formulas for corresponding TCM syndromes provided by famous TCM doctors who were national wide known in China, plus an anti-virus western drugs (such as Entecavir or Tenofovir).
- Taohong Huazhuo Decoction for the Traditional Chinese Medicine (TCM) syndrome: Damp-heat blocking middle jiao
- Soothe the liver and regulate qi Decoction for the TCM syndrome: Liver depression and qi stagnation
- Supplemented Ganbi Decoction for the TCM syndrome: Stagnation of liver qi and spleen deficiency.
- Supplemented Zimu Dan for the TCM syndrome: Yin deficiency of liver and kidney
- Guifu Erxian Decoction for the TCM syndrome: Yang deficiency of spleen and kidney
- Supplemented Ganji Decoction for the TCM syndrome: Internal blood stasis
干预措施: Entecavir or Tenofovir (Drug)
Advanced CMF
Advanced TCM formulas for corresponding TCM syndromes provided by famous TCM doctors who were national wide known in China, plus an anti-virus western drugs (such as Entecavir or Tenofovir).
- Taohong Huazhuo Decoction for the Traditional Chinese Medicine (TCM) syndrome: Damp-heat blocking middle jiao
- Soothe the liver and regulate qi Decoction for the TCM syndrome: Liver depression and qi stagnation
- Supplemented Ganbi Decoction for the TCM syndrome: Stagnation of liver qi and spleen deficiency.
- Supplemented Zimu Dan for the TCM syndrome: Yin deficiency of liver and kidney
- Guifu Erxian Decoction for the TCM syndrome: Yang deficiency of spleen and kidney
- Supplemented Ganji Decoction for the TCM syndrome: Internal blood stasis
干预措施: Advanced - Supplemented Taohong Huazhuo Decoction (Drug)
Advanced CMF
Advanced TCM formulas for corresponding TCM syndromes provided by famous TCM doctors who were national wide known in China, plus an anti-virus western drugs (such as Entecavir or Tenofovir).
- Taohong Huazhuo Decoction for the Traditional Chinese Medicine (TCM) syndrome: Damp-heat blocking middle jiao
- Soothe the liver and regulate qi Decoction for the TCM syndrome: Liver depression and qi stagnation
- Supplemented Ganbi Decoction for the TCM syndrome: Stagnation of liver qi and spleen deficiency.
- Supplemented Zimu Dan for the TCM syndrome: Yin deficiency of liver and kidney
- Guifu Erxian Decoction for the TCM syndrome: Yang deficiency of spleen and kidney
- Supplemented Ganji Decoction for the TCM syndrome: Internal blood stasis
干预措施: Advanced - Soothe the liver and regulate qi Decoction (Drug)
Advanced CMF
Advanced TCM formulas for corresponding TCM syndromes provided by famous TCM doctors who were national wide known in China, plus an anti-virus western drugs (such as Entecavir or Tenofovir).
- Taohong Huazhuo Decoction for the Traditional Chinese Medicine (TCM) syndrome: Damp-heat blocking middle jiao
- Soothe the liver and regulate qi Decoction for the TCM syndrome: Liver depression and qi stagnation
- Supplemented Ganbi Decoction for the TCM syndrome: Stagnation of liver qi and spleen deficiency.
- Supplemented Zimu Dan for the TCM syndrome: Yin deficiency of liver and kidney
- Guifu Erxian Decoction for the TCM syndrome: Yang deficiency of spleen and kidney
- Supplemented Ganji Decoction for the TCM syndrome: Internal blood stasis
干预措施: Advanced - Supplemented Ganbi Decoction (Drug)
Advanced CMF
Advanced TCM formulas for corresponding TCM syndromes provided by famous TCM doctors who were national wide known in China, plus an anti-virus western drugs (such as Entecavir or Tenofovir).
- Taohong Huazhuo Decoction for the Traditional Chinese Medicine (TCM) syndrome: Damp-heat blocking middle jiao
- Soothe the liver and regulate qi Decoction for the TCM syndrome: Liver depression and qi stagnation
- Supplemented Ganbi Decoction for the TCM syndrome: Stagnation of liver qi and spleen deficiency.
- Supplemented Zimu Dan for the TCM syndrome: Yin deficiency of liver and kidney
- Guifu Erxian Decoction for the TCM syndrome: Yang deficiency of spleen and kidney
- Supplemented Ganji Decoction for the TCM syndrome: Internal blood stasis
干预措施: Advanced - Supplemented Zimu Dan (Drug)
Advanced CMF
Advanced TCM formulas for corresponding TCM syndromes provided by famous TCM doctors who were national wide known in China, plus an anti-virus western drugs (such as Entecavir or Tenofovir).
- Taohong Huazhuo Decoction for the Traditional Chinese Medicine (TCM) syndrome: Damp-heat blocking middle jiao
- Soothe the liver and regulate qi Decoction for the TCM syndrome: Liver depression and qi stagnation
- Supplemented Ganbi Decoction for the TCM syndrome: Stagnation of liver qi and spleen deficiency.
- Supplemented Zimu Dan for the TCM syndrome: Yin deficiency of liver and kidney
- Guifu Erxian Decoction for the TCM syndrome: Yang deficiency of spleen and kidney
- Supplemented Ganji Decoction for the TCM syndrome: Internal blood stasis
干预措施: Advanced - Guifu Erxian Decoction (Drug)
Advanced CMF
Advanced TCM formulas for corresponding TCM syndromes provided by famous TCM doctors who were national wide known in China, plus an anti-virus western drugs (such as Entecavir or Tenofovir).
- Taohong Huazhuo Decoction for the Traditional Chinese Medicine (TCM) syndrome: Damp-heat blocking middle jiao
- Soothe the liver and regulate qi Decoction for the TCM syndrome: Liver depression and qi stagnation
- Supplemented Ganbi Decoction for the TCM syndrome: Stagnation of liver qi and spleen deficiency.
- Supplemented Zimu Dan for the TCM syndrome: Yin deficiency of liver and kidney
- Guifu Erxian Decoction for the TCM syndrome: Yang deficiency of spleen and kidney
- Supplemented Ganji Decoction for the TCM syndrome: Internal blood stasis
干预措施: Advanced - Supplemented Ganji Decoction (Drug)
Pure Entecavir or Tenofovir
Use an anti-virus western drug alone (such as Entecavir or Tenofovir).
干预措施: Entecavir or Tenofovir (Drug)
结局指标
主要结局
Traditional Chinese Medicine symptom scale
时间窗: Change of TCM symptom scale between baseline and sixth months of treatment
次要结局
- The change of liver fibrosis(Chnage of liver fibrosis between baseline and 6th months of treatment)
- Overall effectiveness of treatment defined by the guidelines for prevention and treatment of chronic hepatitis B(Overall effectiveness of treatment between baseline and 6th months of treatment)